Bahar Mjos, DO
Evaluating the use of recombinant human activated protein C in adult severe sepsis: Results of the Surviving Sepsis Campaign*
Casserly,
Brian MD; Gerlach, Herwig MD, PhD; Phillips, Gary S. MAS; Marshall, John C. MD;
Lemeshow, Stanley PhD; Levy, Mitchell M. MD
After the PROWESS-SHOCK trial and Cochrane review in 2012,
it appeared that the controversy related to efficacy of activated protein C and
its role in sever sepsis had been resolved. However, this month in the journal
of Critical Care Medicine, revisited this topic.
It has been shown that after adjusting for multiple
confounders, patients who received rhAPC had statistically significantly lower
in-hospital mortality. “Propensity score matching was used to validate the risk
adjusted multivariate regression model, and the results were similar. Patients
with thrombocytopenia and coagulopathy also were found to have lower, and
statistically significant, adjusted risks of hospital mortality”.
As of October 2011 Xigris (activated protein C) has been
withdrawn from the market.
“While further discussions about rhAPC might be considered
moot, it is worth noting that previous rigorously conducted clinical trials
occasionally have yielded discordant results compared to observational, “real-life”
investigations. The recent moratorium on the use of rhAPC appears to represent
yet another failure of immunomodulatory agents to impact outcomes for
critically ill patients with sepsis; however, the infrequent use of rhAPC, in
selected populations, was found to be associated with a significant improvement
in adjusted hospital mortality in this study.”
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